NCT04674059

Brief Summary

The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

December 4, 2020

Last Update Submit

December 15, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • Diagnoses

    Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.

    1 year

  • Diagnostic delay

    Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.

    1 year

  • Number of previous psychiatric hospitalisations

    Numerical value of the previous psychiatric hospitalisations.

    1 year

  • Number of previous crises

    Numerical value of the previous crises defined as an episode of depression or mania or hypomania.

    1 year

  • Types of medical treatment provided

    What type of medical treatment is provided, including brand name, administration and dosage.

    1 year

  • Medical Adherence

    Medication Adherence Rating Scale (MARS) will be used to assess beliefs and barriers to medication adherence. Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.

    1 year

  • The referral pathways

    Who initiated the first contact, who did you seek for help, what kind of help was provided, percent of patients who came in contact with traditional leaders.

    1 year

  • Degree of internal stigma

    Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) will be used to assess self-stigma. The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma.

    1 year

Interventions

A questionnaire will be delivered by the health care providers at Ndera Hospital, Kigali, Rwanda or CHUK, Hospital, Kigali, Rwanda. The questions will explore the patient's clinical characteristics, the current treatment and their experience with the mental health care system.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatients with bipolar disorder in Rwanda

You may qualify if:

  • A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
  • Age ≥ 18 years

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental DisordersBipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood Disorders

Study Officials

  • Per Kallestrup, Prof.

    University of Aarhus

    STUDY CHAIR

Central Study Contacts

Caroline J Arnbjerg, Msc

CONTACT

Emmanuel Musoni Rwililiza, Msc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 17, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share